TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Medical Device Recalled: Class II Recall Explained

Overview

A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.

This specific medical device recall involving TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. is classified as Class II, and was reported on June 24, 2026 by Howmedica Osteonics Corp..

The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.

What Happened

Howmedica Osteonics Corp. initiated action on TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. on June 24, 2026 after identifying a labeling or packaging error. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.

The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.

Affected Products

The product identified in this notice is TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300., manufactured or distributed by Howmedica Osteonics Corp..

Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Part Number: 5521-B-300. UDI: (01)07613327026313(17)260921(10) UZD9IB. Lot Number: UZD9IB.; a reported quantity of 7 units; distribution reported as US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.; origin or reporting location of Mahwah, NJ, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.

Reason

Based on FDA records, this notice was driven by a labeling or packaging error. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.

According to the FDA's Device Enforcement Report database, the stated reason was: "Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal…"